Breast Implant

The FDA is aware of 19 cases of squamous cell carcinoma in scar tissue that forms around breast implants, the agency announced today in a safety communication.

Age-adjusted incidence of anaplastic large-cell lymphoma of the breast rapidly increased in the U.S. between 2000 and 2018, according to a research letter published in JAMA Oncology.

The number of lymphoma cases linked to breast implants increased nearly 28% in the second half of last year, according to the FDA.

Allergan Aesthetics has begun a new campaign to track and identify patients who have had Biocell breast implants or tissue expanders to inform them of risks associated with the product, according to a press release.

The FDA issued warning letters to two breast implant manufacturers the agency contends have failed to comply with regulatory requirements.

Findings that people who ate large amounts of yogurt and dietary fiber had a decreased risk for lung cancer was the top story in hematology/oncology last week.

The FDA issued draft guidance today recommending inclusion of a boxed warning on breast implant labeling to ensure women receive and understand complete information about their benefits and potential risks.

The top stories in hematology/oncology last week both resulted from FDA actions: Allergan’s agreeing to the agency’s request to recall specific models of its breast implants that may be related to a rare type of lymphoma and the agency granting breakthrough therapy designation to the Keytruda-Lenvima combination for hepatocellular carcinoma.

In response to a request from FDA, Allergan recalled specific models of its textured breast implants due to a potential risk for breast implant-associated anaplastic large cell lymphoma.